Ergonomic IV systems and methods

ABSTRACT

An IV catheter system may have a catheter component with a catheter hub, a cannula extending distally from the catheter hub, and a push feature adjacent to the catheter hub. The IV catheter system may also have a needle component with a needle hub, a needle extending distally from the needle hub along an axis, and a grip extending from the needle hub, generally parallel to the axis, with a pull feature. In the insertion configuration, the needle may be positioned within the cannula and the distal end of the needle hub may be seated in a needle port of the catheter hub. In the fluid delivery configuration, the needle may be positioned outside the catheter hub. The push and pull features may be positioned to facilitate manipulation with a single hand to move the IV catheter system from an insertion configuration to a fluid delivery configuration.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/286,292, which was filed on Oct. 5, 2016, and entitled ERGONOMIC IVSYSTEMS AND METHODS, which claims the benefit of U.S. ProvisionalApplication No. 62/247,626, which was filed on Oct. 28, 2015, U.S.Provisional Application No. 62/296,385, which was filed on Feb. 17,2016, U.S. Provisional Patent Application No. 62/247,596, which wasfiled on Oct. 28, 2015, U.S. Provisional Patent Application No.62/296,383, which was filed on Feb. 17, 2016, U.S. Provisional PatentApplication No. 62/247,599, which was filed Oct. 28, 2015, U.S.Provisional Patent Application No. 62/247,617, which was filed on Oct.28, 2015, U.S. Provisional Patent Application Ser. No. 62/247,607, whichwas filed Oct. 28, 2015, U.S. Provisional Patent Application Ser. No.62/247,621, which was filed Oct. 28, 2015, and U.S. Provisional PatentApplication Ser. No. 62/247,624, which was filed Oct. 28, 2015, each ofwhich is incorporated herein by reference in their entirety.

BACKGROUND

The present invention is generally directed to systems and methods forintravenous (“IV”) delivery, by which fluids can be administereddirectly to the vascular system of a patient. More particularly, thepresent invention is directed to IV catheter systems and methods thatfacilitate insertion into the patient and/or motion from an insertionconfiguration to a fluid delivery configuration in which fluid can bedelivered to the patient through the IV catheter system. An IV cathetersystem according to the invention is used broadly herein to describecomponents used to deliver the fluid to the patient, for use inarterial, intravenous, intravascular, peritoneal, and/or non-vascularadministration of fluid. Of course, one of skill in the art may use anIV catheter system to administer fluids to other locations within apatient's body.

Known IV catheter systems and methods have a number of deficiencies.Many such systems require the clinician to use two hands to position theIV catheter system and/or insert the needle into the fluid deliverylocation on the patient (for example, the vein into which fluid is to bedelivered). Further, many such systems require the clinician to use twohands to move the IV catheter system from the insertion configuration toa fluid delivery configuration, in-which the needle is removed from thecannula to permit fluid to be delivered to the vein through the cannula.Thus, the clinician is required to stabilize the patient's arm or otherbody part having the fluid delivery location prior to insertion of theIV catheter system. As a result, extra time is required for theclinician to initiate transfusion. Further, the clinician is unable toperform any other task, such as stabilizing or reassuring the patient,during insertion and/or motion to the fluid delivery configuration.

Accordingly, there is a need for IV catheter systems and methods thatfacilitate IV catheter system placement, insertion, and/or preparationfor fluid delivery. There is a further need for such IV catheter systemsthat are inexpensive, easy to manufacture, and versatile.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention are generally directed to an IVcatheter system with enhanced ergonomics. In some embodiments, the IVcatheter system may be inserted and moved to a fluid deliveryconfiguration with only one hand. The IV catheter system may include acatheter component and a needle component. The catheter component mayhave a catheter hub having a catheter hub distal end and a catheter hubproximal end. The catheter hub may define a chamber extending betweenthe catheter hub distal end and the catheter hub proximal end and aneedle port at the catheter hub proximal end that provides access to thechamber. The catheter hub may also have a cannula extending distallyfrom the catheter hub distal end and a push feature connected to thecatheter hub and defining a push surface of the catheter component. Theneedle component may have a needle hub having a needle hub distal endand a needle extending distally from the needle hub distal end. Theneedle component may also have a pull feature connected to the needlehub and defining a pull surface of the needle component. In theinsertion configuration, the needle may be positioned within thecannula, the needle hub distal end may be seated in the needle port, andthe pull surface may be positioned distal the catheter hub proximal end.

The pull surface may be positioned distal the push surface when the IVcatheter system is in the insertion configuration.

The push feature may include a feature such as a trailing edge of a wingsecured to the catheter hub with the wing being generally parallel to anaxis of the cannula, a grip feature applied to or formed on a majorsurface of a wing secured to the catheter hub with the wing beinggenerally parallel to an axis of the cannula; a series of nubs appliedto or formed on a major surface of a wing secured to the catheter hubwith the wing being generally parallel to an axis of the cannula, a tabsecured to a wing secured to the catheter hub generally parallel to anaxis of the cannula with the tab extending from the wing in a directionnonparallel to the wing, a tab secured to a wing secured to the catheterhub generally parallel to an axis of the cannula with the tab extendingsubstantially perpendicularly from the wing, a tab secured to andextending outwardly from the catheter hub, a circumferential ringdisposed around the catheter hub, or a proximal surface of an extensiontubing junction extending from the catheter hub.

The push feature may be integrated into a securement platform such as awing extending from the catheter hub generally parallel to a cannulaaxis along which the cannula extends such that, in the fluid deliveryconfiguration, the wing rests on skin of a patient receiving fluidthrough the IV catheter system.

The wing may be integrated with an extension tubing junction extendingoutwardly from the catheter hub at a location intermediate the catheterhub distal end and the catheter hub proximal end.

The wing is optionally not coplanar with a cannula axis containing thecannula. Alternatively, the wing is coplanar with a cannula axiscontaining the cannula.

The catheter component may further include a septum within the chamberthrough which the needle passes in the insertion configuration. Theseptum may be configured to provide a sufficiently low resistance towithdrawal of the needle through the septum to enable a single hand of aclinician to move the IV catheter system from the insertionconfiguration to the fluid delivery configuration without assistance ofanother hand of the clinician.

The pull feature may include a feature such as a leading edge of a gripsecured to the needle hub and extending outwardly and generally distallyfrom the needle hub, a grip feature applied to or formed on a majorsurface of a grip secured to the needle hub and extending outwardly andgenerally distally from the needle hub, a series of nubs applied to orformed on a major surface of a grip secured to the needle hub andextending outwardly and generally distally from the needle hub, a tabsecured to a grip secured to the needle hub and extending outwardly andgenerally distally from the needle hub generally parallel to an axis ofthe needle with the tab extending from the grip in a directionnonparallel to the grip, and a tab secured to a grip secured to theneedle hub and extending outwardly and generally distally from theneedle hub generally parallel to an axis of the needle with the tabextending substantially perpendicularly from the grip.

The catheter component may have a wing extending outwardly from thecatheter hub generally parallel to a cannula axis. The needle componentmay have a grip extending outwardly and distally from the needle hubgenerally parallel to a needle axis. In the insertion configuration, thewing and the grip may be generally parallel to each other and may bepositioned in abutting relation to each other. During motion of the IVcatheter system from the insertion configuration to the fluid deliveryconfiguration, the grip may slide along the wing.

The needle component may have a rotation stop feature formed proximatethe needle hub distal end. The rotation stop feature may be configuredto engage a corresponding feature on the catheter component to limitrotation of the needle component relative to the catheter component.

The catheter component may include a wing extending outwardly from thecatheter hub generally parallel to a cannula axis. The needle componentmay include a grip extending outwardly and distally from the needle hubgenerally parallel to a needle axis. A rotation stop feature may extenddistally from the needle hub distal end. In the insertion configuration,the needle component may be rotated relative to the catheter componentsuch that the rotation stop feature contacts the wing of the cathetercomponent and the grip is substantially co-planar with the wing. Therotation stop feature may allow the grip to be rotated overtop the wingbut not underneath the wing.

A gripping or push surface may comprise a circumferential ring extendingaround one or more surfaces of the catheter hub. A low-drag septum maybe disposed within the catheter hub. Opposed side grips may be disposedon opposing sides of the needle hub. A low-volume, high-visualizationflash chamber may be removably attached to a flash receptacle attachedto a proximal end of the needle hub.

The needle component may have a needle hub proximal end having a flashreceptacle containing a flash chamber. The flash receptacle may includeone or more end and/or side vents for venting air from the flashchamber.

In other embodiments, the IV catheter system may be inserted and movedto a fluid delivery configuration with only one hand. The IV cathetersystem may include a catheter component and a needle component. Thecatheter component may include a catheter hub with a catheter hub distalend and a catheter hub proximal end, the catheter hub defining a chamberextending between the catheter hub distal end and the catheter hubproximal end. The catheter component may also include a needle port atthe catheter hub proximal end that provides access to the chamber and acannula extending distally from the catheter hub distal end. Thecatheter component may also include a wing connected to the catheter huband extending outwardly from the catheter hub, the wing having a pushsurface of the catheter component. The needle component may have aneedle hub having a needle hub distal end and a needle extendingdistally from the needle hub distal end. The needle component may alsohave a grip connected to the needle hub and extending outwardly anddistally from the needle hub, the grip comprising a pull surface of theneedle component. In the insertion configuration, the needle may bepositioned within the cannula, the needle hub distal end may be seatedin the needle port, and the pull surface may be positioned distal thecatheter hub proximal end.

The pull surface may be positioned distal the push surface when the IVcatheter system is in the insertion configuration. The push surface maybe a surface such as a trailing edge of the wing, a grip feature appliedto or formed on a major surface of the wing, a series of nubs applied toor formed on a major surface of the wing, a tab secured to the wing andextending from the wing in a direction nonparallel to the wing, a tabsecured to the wing and extending substantially perpendicularly from thewing, or a proximal surface of an extension tubing junction extendingfrom the catheter hub and integrated with the wing.

The pull surface may be a surface such as a leading edge of the grip, agrip feature applied to or formed on a major surface of the grip, aseries of nubs applied to or formed on a major surface of the grip, atab secured to the grip and extending from the grip in a directionnonparallel to the grip, or a tab secured to the grip and tab extendingsubstantially perpendicularly from the grip.

In other embodiments, the IV catheter system may include a rotation stopfeature that limits rotation of the needle component relative to thecatheter component. The IV catheter system may include a cathetercomponent and a needle component. The catheter component may have acatheter hub having a proximal end, a cannula that extends distally fromthe catheter hub, and a wing that extends outwardly from a side of thecatheter hub. The needle component may have a needle hub having a distalend that couples to the proximal end of the catheter hub, a needle thatextends distally from the distal end of the needle hub, and a grip thatextends outwardly and distally from a side of the needle hub. The needlecomponent may also have a rotation stop feature formed at the distal endof the needle hub, the rotation stop feature being adapted to contact acorresponding feature of the catheter component, such as the wing of thecatheter component or another external feature or tab on the cathetercomponent's proximal end to limit rotation of the needle component withrespect to the catheter component when the needle is fully inserted inthe cannula.

The rotation stop feature may extend distally from the distal end of theneedle hub. When the rotation stop feature contacts the wing, a plane ofthe grip may be substantially parallel to a plane of the wing.

In other embodiments, the IV catheter system may be inserted and movedto the fluid delivery configuration with only one hand. The IV cathetersystem may have a catheter component and a needle component. Thecatheter component may have a catheter hub with a catheter hub distalend and a catheter hub proximal end. The catheter hub may be shaped todefine a chamber extending between the catheter hub distal end and thecatheter hub proximal end, and a needle port at the catheter hubproximal end that provides access to the chamber. The catheter componentmay also have a cannula extending distally from the catheter hub distalend along a cannula axis, and a push feature positioned proximate thecatheter hub to define a push surface oriented substantiallyperpendicular to the cannula axis. The needle component may have aneedle hub with a needle hub distal end and a needle hub proximal end, aneedle extending distally from the needle hub distal end along a needleaxis, and a grip extending from the needle hub, generally parallel tothe axis. The grip may have a pull feature. In an insertionconfiguration, the needle may be positioned within the cannula and theneedle hub distal end may be seated in the needle port. In a fluiddelivery configuration, the needle may be positioned outside thecatheter hub. The push feature and the pull feature may be positioned toreceive contact from digits of a single hand to urge the IV cathetersystem to move from the insertion configuration to the fluid deliveryconfiguration.

The catheter hub may have a catheter hub intermediate portion betweenthe catheter hub proximal end and the catheter hub distal end. Thecatheter component may further have an extension tubing junctionextending outwardly from the catheter hub intermediate portion toconnect the catheter hub to extension tubing.

The catheter component may further have a securement platform with afirst wing extending from the catheter hub, generally parallel to thecannula axis. In the fluid delivery configuration, the first wing mayrest on skin of a patient receiving fluid through the IV cathetersystem. The first wing may be integrated with the extension tubingjunction.

The catheter component may further have a septum within the chamber,through which the needle passes in the insertion configuration. Theseptum may be configured to provide a sufficiently low resistance towithdrawal of the needle through the septum to enable the hand, alone,to move the IV catheter system from the insertion configuration to thefluid delivery configuration.

The catheter component may further have a securement platform with afirst wing extending from the catheter hub, generally parallel to thecannula axis. In the fluid delivery configuration, the first wing mayrest on skin of a patient receiving fluid through the IV cathetersystem.

The push feature may be a tab secured to the first wing. The tab mayextend from the first wing along a direction nonparallel to the firstwing.

In the insertion configuration, the first wing and the grip may begenerally parallel to each other and may be positioned in abuttingrelation to each other. During motion of the IV catheter system from theinsertion configuration to the fluid delivery configuration, the gripmay slide along the first wing.

The push feature may be a tab secured to the catheter hub. The tab mayextend outwardly from the catheter hub.

The tab may be positioned proximate the catheter hub proximal end.Specifically, the tab may be positioned closer to the catheter hubproximal end than to the catheter hub distal end.

The pull feature may be a leading edge of the grip. The leading edge maybe shaped and sized to comfortably receive contact from one of thedigits.

The pull feature may be a tab secured to the grip. The tab may extendfrom the grip along a direction nonparallel to the grip.

The IV catheter system may further have a flash receptacle secured tothe needle hub proximal end. The flash receptacle may be shaped todefine a flash chamber that receives blood in response to positioning ofa distal end of the cannula in a blood vessel.

In other embodiments, the IV catheter system may be inserted and movedto the fluid delivery configuration with only one hand. The IV cathetersystem may have a catheter component and a needle component. Thecatheter component may have a catheter hub with a catheter hub distalend and a catheter hub proximal end. The catheter hub may be shaped todefine a chamber extending between the catheter hub distal end and thecatheter hub proximal end. The catheter hub may further have a needleport at the catheter hub proximal end that provides access to thechamber. The catheter component may further have a cannula extendingdistally from the catheter hub distal end along a cannula axis, a pushfeature positioned proximate the catheter hub, and a securement platformwith a first wing extending from the catheter hub, generally parallel tothe cannula axis. In a fluid delivery configuration, the first wing mayrest on skin of a patient receiving fluid through the IV cathetersystem. The first wing may not be coplanar with the cannula axis. Theneedle component may have a needle hub with a needle hub distal end anda needle hub proximal end, a needle extending distally from the needlehub distal end along a needle axis, and a grip extending from the needlehub, generally parallel to the needle axis. The grip may have a pullfeature. In an insertion configuration, the needle may be positionedwithin the cannula and the needle hub distal end may be seated in theneedle port. In the fluid delivery configuration, the needle may bepositioned outside the catheter hub. The push feature and the pullfeature may be positioned to receive contact from digits of a singlehand to urge the IV catheter system to move from the insertionconfiguration to the fluid delivery configuration.

The catheter hub may have a catheter hub intermediate portion betweenthe catheter hub proximal end and the catheter hub distal end. Thecatheter component may further have an extension tubing junctionextending outwardly from the catheter hub intermediate portion toconnect the catheter hub to extension tubing.

The catheter component may further have a securement platform with afirst wing extending from the catheter hub, generally parallel to thecannula axis. In the fluid delivery configuration, the first wing mayrest on skin of a patient receiving fluid through the IV cathetersystem. The first wing may be integrated with the extension tubingjunction.

The catheter component may further have a septum within the chamber,through which the needle passes in the insertion configuration. Theseptum may be configured to provide a sufficiently low resistance towithdrawal of the needle through the septum to enable the single hand,alone, to move the IV catheter system from the insertion configurationto the fluid delivery configuration.

The push feature may be a tab secured to the first wing. The tab mayextend from the first wing along a direction nonparallel to the firstwing.

In other embodiments, the IV catheter system may be inserted and movedto the fluid delivery configuration with only one hand. The IV cathetersystem may have a catheter component and a needle component. Thecatheter component may have a catheter hub with a catheter hub distalend and a catheter hub proximal end. The catheter hub may be shaped todefine a chamber extending between the catheter hub distal end and thecatheter hub proximal end, and a needle port at the catheter hubproximal end that provides access to the chamber. The catheter componentmay further have a cannula extending distally from the catheter hubdistal end along a cannula axis, and a push feature positioned proximatethe catheter hub. The needle component may have a needle hub with aneedle hub distal end and a needle hub proximal end, a needle extendingdistally from the needle hub distal end along a needle axis, and a firstgrip extending from the needle hub, generally parallel to the needleaxis. The first grip may have a first pull feature positioned distallyof the needle hub distal end. The needle component may further have asecond grip extending from the needle hub, generally parallel to theneedle axis. The second grip may have a second pull feature positionedproximally of the first pull feature. In an insertion configuration, theneedle may be positioned within the cannula and the needle hub distalend may be seated in the needle port. In a fluid delivery configuration,the needle may be positioned outside the catheter hub. The push feature,the first pull feature, and the second pull feature may be positioned toreceive contact from digits of a single hand to urge the IV cathetersystem to move from the insertion configuration to the fluid deliveryconfiguration.

The second grip may be substantially coplanar with the first grip. Thesecond grip may further be positioned on an opposite side of thecatheter hub from the first grip.

The catheter component may further have a securement platform with afirst wing extending from the catheter hub, generally parallel to thecannula axis. In the fluid delivery configuration, the first wing mayrest on skin of a patient receiving fluid through the IV cathetersystem. In the insertion configuration, the first wing and the firstgrip may be generally parallel to each other and may be positioned inabutting relation to each other. During motion of the IV catheter systemfrom the insertion configuration to the fluid delivery configuration,the first grip may slide along the first wing.

In other embodiments, the IV catheter system may include a rotation stopfeature that limits rotation of the needle component with respect to thecatheter component. The IV catheter system may have a catheter componentand a needle component. The catheter component may have a catheter huband a cannula that extends distally from the catheter hub. The cathetercomponent may further have an extension tubing junction which extendsoutwardly from a first side of the catheter hub and couples extensiontubing to the catheter hub. The catheter component may also have and afirst wing that extends outwardly from the first side. The needlecomponent may have a needle hub having a distal end that couples to aproximal end of the catheter hub and a needle that extends distally fromthe needle hub. The needle component may also have a grip that extendsoutwardly from a second side of the needle hub and a rotation stopfeature formed at the distal end of the needle hub. The rotation stopfeature may contact the catheter component to limit rotation of theneedle component with respect to the catheter component.

The rotation stop feature may include a feature on the needle hub and acorresponding feature on the catheter hub. The feature on the needle hubmay extend distally from the distal end of the needle hub, may be anexternal feature at the distal end of the needle hub, or may be aninternal feature at the distal end of the needle hub. The feature on theneedle hub and/or the corresponding feature on the catheter hub may eachcomprise a single surface or feature, or alternatively may each comprisea plurality of compatible surfaces or features. The feature on thecatheter hub may be an external feature or tab on the catheter hub, andmay be a feature of the catheter hub that serves additional purposes,such as the first wing of the catheter system. The rotation stop featuremay extend distally from the distal end of the needle hub and contactthe first wing of the catheter component. When the rotation stop featurecontacts the first wing, the grip may be substantially in-line with thefirst wing. The rotation stop feature may allow the grip to be rotatedovertop the first wing but not underneath the first wing. The rotationstop feature may form a ledge that contacts an underside of the firstwing.

The grip may include a pull feature and the first wing may include apush feature. A proximal end of the needle component may include a flashreceptacle containing a flash chamber. The flash receptacle may includeone or more side vents for venting air from the flash chamber. The flashreceptacle may also include a proximal opening for venting air from theflash chamber. The flash receptacle may be removable from the needlehub.

In other embodiments, the IV catheter system may include a flashreceptacle having one or more side vents for venting air from within theflash chamber. The IV catheter system may have a catheter component anda needle component. The catheter component may include a catheter huband a cannula that extends distally from the catheter hub. The cathetercomponent may also include an extension tubing junction which extendsoutwardly from a first side of the catheter hub and couples extensiontubing to the catheter hub and a first wing that extends outwardly fromthe first side. The needle component may include a needle hub having adistal end that couples to a proximal end of the catheter hub, a needlethat extends distally from the needle hub, and a grip that extendsoutwardly from a second side of the needle hub. The needle hub mayfurther include a flash receptacle formed at a proximal end of theneedle component and including a flash chamber. The flash receptacle mayinclude one or more side vents for venting air from within the flashchamber. The flash receptacle may also include a proximal opening forventing air from within the flash chamber.

These and other features and advantages of the present invention may beincorporated into certain embodiments of the invention and will becomemore fully apparent from the following description and appended claims,or may be learned by the practice of the invention as set forthhereinafter. The present invention does not require that all theadvantageous features and all the advantages described herein beincorporated into every embodiment of the invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In order that the manner in which the above-recited and other featuresand advantages of the invention are obtained will be readily understood,a more particular description of the invention briefly described abovewill be rendered by reference to specific embodiments thereof that areillustrated in the appended drawings. These drawings depict only typicalembodiments of the invention and are not therefore to be considered tolimit the scope of the invention.

FIG. 1 is a perspective view of an IV catheter system according to oneembodiment;

FIGS. 2A and 2B are an exploded perspective view of an IV cathetersystem according to one alternative embodiment, and a fully assembledview of a portion of the IV catheter system, respectively;

FIG. 3 is a perspective views of a portion of an IV catheter systemaccording to another alternative embodiment;

FIG. 4 is a perspective view of an IV catheter system according toanother alternative embodiment;

FIGS. 5A and 5B are perspective views of an IV catheter system accordingto another alternative embodiment;

FIG. 6 is a flowchart diagram depicting one method of preparing an IVcatheter system to deliver fluid to a patient, according to oneembodiment;

FIG. 7A is a perspective view of an IV catheter system according toanother alternative embodiment;

FIG. 7B is a perspective view of an IV catheter system according toanother alternative embodiment;

FIG. 8 is a perspective view of an IV catheter system according toanother alternative embodiment; and

FIGS. 9A and 9B are perspective views of an IV catheter system accordingto another alternative embodiment.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiments of the present invention can beunderstood by reference to the drawings, wherein like reference numbersindicate identical or functionally similar elements. It will be readilyunderstood that the components of the present invention, as generallydescribed and illustrated in the figures herein, could be arranged anddesigned in a wide variety of different configurations. Thus, thefollowing more detailed description, as represented in the figures, isnot intended to limit the scope of the invention as claimed, but ismerely representative of presently preferred embodiments of theinvention.

Moreover, the Figures may show simplified or partial views, and thedimensions of elements in the Figures may be exaggerated or otherwisenot in proportion for clarity. In addition, the singular forms “a,”“an,” and “the” include plural referents unless the context clearlydictates otherwise. Thus, for example, reference to a terminal includesreference to one or more terminals. In addition, where reference is madeto a list of elements (e.g., elements a, b, c), such reference isintended to include any one of the listed elements by itself, anycombination of less than all of the listed elements, and/or acombination of all of the listed elements.

The term “substantially” means that the recited characteristic,parameter, or value need not be achieved exactly, but that deviations orvariations, including for example, tolerances, measurement error,measurement accuracy limitations and other factors known to those ofskill in the art, may occur in amounts that do not preclude the effectthe characteristic was intended to provide.

As used herein, the term “proximal,” “top,” “up,” or “upwardly” refersto a location on the device that is closest to the clinician using thedevice and farthest from the patient in connection with whom the deviceis used when the device is used in its normal operation. Conversely, theterm “distal,” “bottom,” “down,” or “downwardly” refers to a location onthe device that is farthest from the clinician using the device andclosest to the patient in connection with whom the device is used whenthe device is used in its normal operation.

As used herein, the term “in” or “inwardly” refers to a location withrespect to the device that, during normal use, is toward the inside ofthe device. Conversely, as used herein, the term “out” or “outwardly”refers to a location with respect to the device that, during normal use,is toward the outside of the device. Further, as used herein, a“cannula” is a tube that can be inserted into the body for deliveryand/or removal of fluid. A cannula may be rigid or flexible, and may beformed of any material, including but not limited to metals, ceramics,polymers, elastomers, and composite materials.

As used herein, the term “connected,” “attached,” or “secured,” and thelike when used to refer to the relationship of one component withrespect to another component are intended primarily to define a spatialrelationship unless otherwise indicated, and should be understood toembrace instances where the two components are integrally formed witheach other as well as instances when the two components are separatelyformed and then later secured to one another.

FIG. 1 is a perspective view of an IV catheter system 100 according toone embodiment. The IV catheter system 100 may be connected to a supplyof fluid to be infused. The fluid supply (not shown) may include a bagof blood or medication to be delivered to the patient, a drip chamberthat regulates flow of the fluid to the IV catheter system 100, and/orother components involved with the supply of fluid to the IV cathetersystem 100. The IV catheter system 100 may have a number of components,as shown in the exemplary embodiment of FIG. 1 . These components mayinclude a catheter component 102, a needle component 104, an extensiontube 106, a clamp 108, a Y adapter 110, and/or a flash receptacle 112.

The catheter component 102 may be inserted into the fluid deliverylocation in the patient in order to convey the fluid to the patient. Theneedle component 104 may facilitate insertion of the catheter component102 to the fluid delivery location. The extension tube 106 may conveythe fluid to the catheter component 102. The clamp 108 may be used tomanually block fluid flow to the catheter component 102 when it isdesired to stop or pause fluid delivery. The Y adapter 110 may have luerlock fittings that are readily connected to the fluid supply and/orother fluid-carrying components, for example, via connection to acomplementary luer lock (not shown) of the fluid supply or other fluidcomponents. The flash receptacle 112 may have a flash chamber 114 thatreceives blood when the IV catheter system 100 has been positioned toaccess a blood vessel. The flash receptacle 112 may thus indicate properinsertion of the IV catheter system 100.

As embodied in FIG. 1 , the IV catheter system 100 may be an integratedIV catheter system, as the extension tube 106 is pre-attached to thecatheter component 102. In other embodiments, IV catheter systems ofvarious open, integrated, and/or safety integrated configurations may beused.

The catheter component 102 may have various components, which mayinclude a catheter hub 120, a securement platform 122, an extensiontubing junction 124, and a cannula 126. The catheter hub 120 may have agenerally tubular and/or hollow conical configuration, and may have aproximal end 130 and a distal end 132. The catheter hub 120 may beshaped to define a chamber 134 through which the fluid flows to reachthe fluid delivery location. The catheter hub 120 may have a needle port136 at the proximal end 130. The chamber 134 may contain a septum (notvisible) that is designed to block flow of blood and/or the fluid to bedelivered from the chamber 134 through the needle port 136. The cannula126 may be secured to the distal end 132 of the catheter hub 120, andmay extend distally of the distal end 132 along a cannula axis 128.

The securement platform 122 may have a generally planar configurationdesigned to permit the securement platform 122 to be secured to the skinof the patient, proximate the fluid delivery location, to keep thecatheter component 102 securely in place as fluid delivery takes place.As embodied in FIG. 1 , the securement platform 122 may have a firstwing 140 with a generally planar shape, and the plane of the first wing140 may be generally parallel the cannula axis 128. The first wing 140may be fixedly secured to the catheter hub 120, and may have a generallysemicircular shape when viewed from along a direction perpendicular tothe plane of the first wing 140. The first wing 140 may have a trailingedge 144 oriented toward the proximal end 130 of the catheter hub 120,with the trailing edge 144 forming or capable of being used as a pushsurface. Other surfaces of the first wing 140 and/or the securementplatform 122 may also optionally serve as a push surface. The first wing140 and/or the push surface of the first wing 140 are examples of a pushfeature of the catheter component 102. As part of the securementplatform 122, the first wing 140 may be adapted to rest on skin of apatient receiving fluid through the IV catheter system 100.

In alternative embodiments (not shown), a securement platform may alsoinclude a second wing, which may optionally be coplanar with the firstwing 140. Such a second wing may extend in the opposite direction,relative to the catheter hub, from the first wing 140. If desired, thesecond wing may be symmetrical to the first wing 140. Such a second wingmay also have a trailing edge that can be used as a push surface, inaddition to or in the alternative to use of the trailing edge 144 of thefirst wing 140. The second wing may provide additional options forgripping the catheter component 102 for insertion and/or motion to thefluid delivery configuration, and is another example of a push feature.

The first wing 140 may not be coplanar with the cannula axis 128 butmay, instead, be offset from the cannula axis 128. Thus, the first wing140 may not intersect the midline of the catheter hub 120.Alternatively, the first wing 140 may be coplanar with the cannula axis128. The first wing 140 may be integrated with the extension tubingjunction 124 such that the extension tubing junction 124 divides thefirst wing 140 into a leading portion and a trailing portion having thetrailing edge 144. Thus, the axis of the extension tubing junction 124may also not be coplanar with the cannula axis 128, but may rather becoplanar with the first wing 140 and offset from the cannula axis 128.Alternatively, the axis of the extension tubing junction 124 may becoplanar with the cannula axis and the first wing 140, or with only oneof them.

The needle component 104 may have a needle hub 150, a grip 152, and aneedle 154. The needle hub 150 may be detachably coupled to the catheterhub 120 of the catheter component 102. The grip 152 may extend outwardfrom the needle hub 150. The needle 154 may be removably positionedwithin the cannula 126 such that the needle 154 facilitates the processof accessing the fluid delivery location (for example, a vein) andproper positioning of the cannula 126 to deliver the fluid to the fluiddelivery location. The needle 154 may extend distally from the needlehub 150 along a needle axis, which may be coincident with the cannulaaxis 128 when the IV catheter system 100 is in an insertionconfiguration, as shown in FIG. 1 .

The needle hub 150 may have a generally tubular shape with a proximalend 160 and a distal end 162. The needle hub 150 may have a boss 164positioned at the distal end 162; the boss 164 may be insertable intothe needle port 136 of the catheter hub 120 of the catheter component102.

The grip 152 may have a generally planar shape that extends outward fromthe needle hub 150. Additionally, the grip 152 may extend distally fromthe needle hub 150. When viewed from a direction perpendicular to theplane of the grip 152, the grip 152 may have an oblong and/or partiallyelliptical shape, with a proximal portion 166 with a relatively narrowshape, and a distal portion 168 with a broader shape. The proximalportion 166 may extend outward from the needle hub 150, coplanar withthe needle axis (and thus coplanar with the cannula axis 128 when the IVcatheter system 100 is in the insertion configuration). Alternatively,the grip 152 may extend generally outward and distally from the needlehub 150 without being coplanar with the needle axis, and a plane of thegrip 152 may optionally be generally parallel to the needle axis. Thegrip 152 and the first wing 140 may have one or more grip features (notshown), which may help provide a secure interface that facilitatesgripping and/or moving the grip 152 by hand relative to the first wing140. The grip features are one example of features that may serve as apush feature or a pull feature. The grip 152 may have a leading edge172, which may form or serve as a pull surface of the needle component104, and the leading edge 172 is another example of a pull feature.

The IV catheter system 100 is illustrated in FIG. 1 in the insertionconfiguration, in which the IV catheter system 100 is readily insertableto position the cannula 126 in the fluid delivery location. The IVcatheter system 100 also has a fluid delivery configuration, in whichthe fluid flow through the cannula 126 is relatively unimpeded. In theinsertion configuration, the needle 154 is positioned within the cannula126 to provide a sharpened tip for penetrating tissue and a relativelystiff body that supports the cannula 126 during insertion. The boss 164of the needle hub 150 is positioned within the needle port 136 of thecatheter hub 120. The needle 154 passes through the septum (not shown)of the catheter component 102. Additionally, the pull feature of theneedle component 104 (e.g. leading edge 172) is positioned distally ofthe proximal end 130 of the catheter component 102 as well as distallyof the push feature of the catheter component 102 (e.g. trailing edge144).

The IV catheter system 100 may be inserted into position by positioningthe tip of the cannula 126 proximate the fluid delivery location (forexample, the patient's vein). The securement platform 122 may be placedon the patient's skin, proximate the fluid delivery location and/or heldin the clinician's hand. The catheter component 102 and the needlecomponent 104 may be advanced together to push the cannula 126 until thetip of the cannula 126 penetrates the surrounding tissue and reaches thefluid delivery location. If desired, the catheter component 102 may beadvanced by pushing a push surface of the catheter component 102. The“push surface” is a surface that is generally proximally oriented, andthus can receive contact from the clinician's hand to urge the cathetercomponent 102 and the needle component 104, together, distally.

Once the tip of the cannula 126 has reached the fluid delivery location,the IV catheter system 100 may be moved to the fluid deliveryconfiguration. This may be done by withdrawing the needle component 104proximally from the catheter component 102. This may initially cause theboss 164 to be withdrawn proximally from within the needle port 136. Theneedle 154 may also be withdrawn proximally from the cannula 126, andthen through the chamber 134, including the septum (not shown). Theneedle 154 may pass out of the chamber 134 through the needle port 136,thus completing motion of the IV catheter system 100 to the fluiddelivery configuration. Fluid flow to the fluid delivery location maynow be accomplished by urging the fluid to flow through the extensiontube 106, into the chamber 134, and through the cannula 126 to the fluiddelivery location.

The IV catheter system 100 may advantageously be designed to facilitateinsertion to the fluid delivery location with a single hand. Forexample, during insertion, the clinician may, with one hand, hold thecatheter component 102 and the needle component 104, for example, bygrasping the securement platform 122 and the grip 152. The clinician maythen, with the same hand, apply gentle pressure to one or more pushsurfaces of the catheter component 102 (for example, the trailing edge144 of the first wing 140) to urge the tip of the cannula 126 topenetrate the patient's skin and ultimately reach the fluid deliverylocation. If desired, one or more locking features (not shown) may beused to hold the catheter component 102 and the needle component 104together until the clinician applies a threshold force to move the IVcatheter system 100 from the insertion configuration to the fluiddelivery configuration. Such locking features may take the form ofinterlocking features (not shown) between the boss 164 and the needleport 136, and/or the like.

The IV catheter system 100 may be designed to provide visualconfirmation of proper placement in a blood vessel. For example, atleast a portion of the catheter hub 120 may be translucent to providevisibility into the chamber 134. Thus, when the tip of the cannula 126enters a vein, the resulting blood flow, or “flash,” may be visiblethrough the exterior wall of the catheter hub 120 as the blood entersthe chamber 134. The extension tubing junction 124 and the extensiontube 106 may also, optionally, be translucent. In some embodiments, theflash may extend through the extension tube 106 to the Y adapter 110.The Y adapter 110 may be coupled to the fluid supply in a manner thatsubstantially prevents blood leakage. Further, the flash receptacle 112may indicate flash by receiving blood within the flash chamber 114. Ifdesired, the flash receptacle 112 may be vented so that it can bedisconnected from the needle component 104 without discharging collectedblood. This may help reduce infection risk and/or facilitate use of theflash receptacle 112 to collect blood samples for testing.

Further, the IV catheter system 100 may advantageously be designed tofacilitate motion from the insertion configuration to the fluid deliveryconfiguration with a single hand. For example, the clinician may, with asingle hand, which may be the same hand used to insert the IV cathetersystem 100 into the fluid delivery location, grasp the cathetercomponent 102 and the needle component 104 and withdraw the needlecomponent 104 proximally from the catheter component 102. The cathetercomponent 102 may be left substantially in place so that only the needlecomponent 104 moves significantly to move the IV catheter system 100from the insertion configuration to the fluid delivery configuration.

This may be done by placing digits of the hand to contact the pullsurface(s) of the needle component 104 and the push surface(s) of thecatheter component 102, and then with those digits, pulling the needlecomponent 104 proximally (as indicated by the arrow 190) while pushingor bracing the catheter component 102 distally (as indicated by thearrow 192) relative to the needle component 104 to keep it from movingproximally with the needle component 104. For example, the trailing edge144 of the first wing 140 or of the securement platform 122 may act as apush surface, while the leading edge 172 of the grip 152 may act as apull surface. The clinician may place one or more fingers on the leadingedge 172 of the grip 152 and pull proximally, while pushing and/orbracing with a thumb and/or one or more other fingers on the trailingedge 144 of the first wing 140 of the securement platform 122. Thus, thecatheter component 102 may be kept in place with the tip of the cannula126 at the fluid delivery location while the needle component 104 iswithdrawn proximally from the catheter component 102 to unblock thefluid delivery path to the fluid delivery location.

The relative positions of the pull and push surfaces may facilitatesingle-handed operation in the manner described above. The offset of thefirst wing 140 from the cannula axis 128 (or alternatively of the grip152 from the needle axis) may also facilitate such single-handedoperation by ensuring that the first wing 140 and the grip 152 arespaced apart, thereby providing adequate space for a digit to contactthe trailing edge 144 without interference from the grip 152, and tocontact the leading edge 172 without interference from the first wing140. The relative distal/proximal positions of the one or more pushsurfaces of the catheter component 102 and the one or more pull surfacesof the needle component 104 may facilitate one-handed movement to thefluid delivery position. If desired, the coupling of the needle hub 150with the catheter hub 120 may be such that the needle hub 150 isrotatable relative to the catheter hub 120 while the IV catheter system100 is in the insertion configuration. Thus, the clinician may, with thehand, rotate the grip 152 to an orientation that is most comfortable forpulling on the leading edge 172, prior to pulling on the leading edge172 and pushing and/or bracing on the trailing edge 144.

The septum (not shown) may have a “low friction” or “low drag” designconfigured to provide relatively low resistance to withdrawal of theneedle 154 proximally through the septum, which occurs as the IVcatheter system 100 transitions from the insertion configuration to thefluid delivery configuration. The resistance to withdrawal of the needle154 through the septum may be sufficiently low that the clinician canrelatively easily move the IV catheter system 100 from the insertionconfiguration to the fluid delivery configuration with only a singlehand. In some embodiments, the resistance to withdrawal may be, onaverage, less than about 50 gf.

FIGS. 2A and 2B are an exploded perspective view of an IV cathetersystem 200 according to one alternative embodiment, and a fullyassembled view of a portion of the IV catheter system 200, respectively.The IV catheter system 200 may have components that generally correspondto those of the IV catheter system 100 of FIG. 1 . As shown in FIG. 2A,the IV catheter system 200 may have a catheter component 202, a needlecomponent 204, an extension tube 206, a clamp 208, a luer lock adapter210, and a flash receptacle 212. The luer lock adapter 210 may besimilar to the Y adapter 110, but may include only a single fittingdesigned to be connected to a fluid source or other component. FIG. 2Billustrates only the catheter component 202, the needle component 204,and the distal end of the extension tube 206 connected to the cathetercomponent 202. The IV catheter system 200 may have a configurationsimilar to that of the IV catheter system 100 of FIG. 1 ; however, somecomponents may be modified, added, or omitted to provide alternativeergonomics and/or functionality.

The catheter component 202 may have a catheter hub 220, a securementplatform 222, an extension tubing junction 224, and a cannula 226. Thecatheter hub 220 may have a generally tubular and/or hollow conicalshape, with a proximal end 230 and a distal end 232. The catheter hub220 may have a generally translucent exterior wall shaped to define achamber 234 through which fluid flows to reach the fluid deliverylocation through the cannula 226. The catheter hub 220 may have a needleport 236 that connects to the needle component 204, proximate theproximal end 230 of the catheter hub 220. The catheter hub 220 may alsohave a septum 238 positioned within the chamber 234. The septum 238 maybe a “low drag” septum as described previously.

Further, the catheter hub 220 may have a kink resistance feature thathelps to avoid kinking of the cannula 226 during insertion and/orinfusion. The kink resistance feature may take the form of a proximalextension 228 on the distal end 232 of the catheter hub 220. Theproximal extension 228 may receive the cannula 226, and may provide someresistance to bending of the cannula 226 at the juncture of the cannula226 to the distal end 232 to relieve the bending strain of the cannula226 at that location, thereby helping avoid kinking or other undesiredbending of the cannula 226. If desired, the proximal extension 228 maybe formed of a more flexible material than that of the remainder of thecatheter hub 220, so as to allow some flexure to help prevent kinking.

The securement platform 222 may be attached to the skin of the patientduring fluid delivery to keep the cannula 226 in place at the fluiddelivery location. The securement platform 222 may have a first wing240, which may be generally planar in shape. The first wing 240 may havea generally triangular shape when viewed from perpendicular to the planeof the first wing 240, with a trailing edge 244 that can act as a pushsurface. As in the previous embodiment, the first wing 240 mayoptionally be offset from a cannula axis (not shown) of the cannula 226.Alternatively, if desired, the first wing 240 may be coplanar with thecannula axis. Similarly, the first wing 240 may be integrated with ormerely adjacent to the extension tubing junction 224.

A tab 246 may be secured to the first wing 240. The tab 246 may beintegrally formed with the first wing 240, or may be formed separatelyfrom the first wing 240 and attached to the first wing 240 through anyof various methods known in the art. The tab 246 may extendsubstantially perpendicular to the plane of the first wing 240, or at amodest angle away from perpendicular to the plane of the first wing 240(e.g. any angle small enough from perpendicular to allow a proximallyoriented surface of the tab 246 to continue to serve as a push surface).Thus, the proximally oriented surface of the tab 246 may serve as a pushsurface, and may be oriented substantially perpendicular to the cannulaaxis (not shown) of the cannula 226 or at a modest angle away fromperpendicular to the cannula axis as described. Alternatively, the tab246 may extend from the first wing 240 along a direction nonparallel tothe plane of the first wing 240.

The needle component 204 may have a needle hub 250, a grip 252, and aneedle 254. The needle hub 250 may have a generally cylindrical shapewith a proximal end 260 and a distal end 262. The needle hub 250 mayalso have a boss 264 that protrudes from the distal end 262 to interfacewith the needle port 236 of the catheter hub 220.

The grip 252 may have a generally planar shape, with an irregular,elongated shape when viewed from perpendicular to the plane of the grip252. The grip 252 may have a proximal portion 266 with a relativelynarrow shape, and a distal portion 268 with an enlarged shape. Theproximal portion 266 may extend outward from the needle hub 250, and maybe generally coplanar with the needle axis (not shown), and thus withthe axis of the needle hub 250. The distal portion 268 of the grip 252may have a leading edge 272, which may serve as a pull surface. The grip252 and/or the first wing 240 may have one or more grip features 270,such as raised nubs, bumps, or ridges of any desirable shape and number,or a high-friction surface applied to the first wing 240 or from which aportion of the first wing 240 may be formed, which may help provide asecure interface that facilitates gripping and/or moving the grip 252and/or the first wing 240 by hand. The grip features 270 are an exampleof a feature that may serve as a push feature or a pull feature.

The grip 252 and the first wing 240 may be rotatable, relative to eachother, about the cannula axis of the cannula 226 and the needle axis ofthe needle 254, which may be coincident in the insertion configurationshown in FIG. 2B. Thus, the clinician may rotate the grip 252 and/or thefirst wing 240 to the desired relative orientation prior to insertionand/or prior to motion to the fluid delivery configuration. In onemethod, the clinician may rotate the grip 252 such that the extensiontubing junction 224 and/or the tab 246 are sandwiched between the grip252 and the first wing 240.

The flash receptacle 212 may function in a manner similar to that of theflash receptacle 112 of the previous embodiment. Specifically, when thedistal end of the cannula 226 enters a blood vessel, blood may flowthrough the catheter hub 220, through the needle hub 250, and into aflash chamber 214 of the flash receptacle 212. Thus, the clinician mayhave visual confirmation of proper placement of the distal end of thecannula 226.

To move the IV catheter system 200 from the insertion configuration tothe fluid delivery configuration, the clinician may position a digit(for example, a finger) on the leading edge 272 of the grip 252, and adigit (for example, a finger or thumb) on the trailing edge 244 of thefirst wing 240 and/or the proximally oriented surface of the tab 246.The clinician may then pull the leading edge 272 of the grip 252proximally, and may push and/or brace the trailing edge 244 of the firstwing 240 and/or the proximally oriented surface of the tab 246 distally.This may cause the catheter component 202 to remain in place while theneedle component 204 is withdrawn proximally from the catheter component202.

FIG. 3 is a perspective view of a portion of an IV catheter system 300according to another alternative embodiment. The IV catheter system 300may have components that generally correspond to those of the IVcatheter systems of previous embodiments. FIG. 3 shows only a cathetercomponent 302 and a needle component 304. The IV catheter system 300 maybe of an “open” type rather than an “integrated type,” and may thus nothave pre-attached extension tubing. Rather, extension tubing may becoupled to the proximal end of the catheter component 302 to supply thefluid. The IV catheter system 300 may otherwise have a configurationsimilar those of previous embodiments; however, some components may bemodified, added, or omitted to provide alternative ergonomics and/orfunctionality.

The catheter component 302 may have a catheter hub 320, a securementplatform 322, and a cannula 326. The catheter hub 320 may have agenerally tubular and/or hollow conical shape, with a proximal end 330and a distal end 332. The catheter hub 320 may have a generallytranslucent exterior wall shaped to define a chamber 334 through whichfluid flows to reach the fluid delivery location through the cannula326. The catheter hub 320 may have a needle port 336 that connects tothe needle component 304, proximate the proximal end 330 of the catheterhub 320. The catheter hub 320 may also have a septum (not shown)positioned within the chamber 334. The septum may be a “low drag” septumas described previously. No extension tubing junction may be present,since the extension tubing is to be coupled to the proximal end 330 ofthe catheter hub 320.

Further, the catheter hub 320 may have a kink resistance feature thathelps to avoid kinking of the cannula 326 during insertion and/orinfusion. The kink resistance feature may take the form of a proximalextension 328 on the distal end 332 of the catheter hub 320. Theproximal extension 328 may receive the cannula 326, and may provide someresistance to bending of the cannula 326 at the juncture of the cannula326 to the distal end 332 to relieve the bending strain at thatlocation, thereby helping avoid kinking or other undesired bending ofthe cannula 326. If desired, the proximal extension 328 may be formed ofa more flexible material than that of the remainder of the catheter hub320, so as to allow some flexure to help prevent kinking.

The securement platform 322 may be attached to the skin of the patientduring fluid delivery to keep the cannula 326 in place at the fluiddelivery location. The securement platform 322 may have a first wing340, which may be generally planar in shape. The first wing 340 may havea generally triangular shape when viewed from perpendicular to the planeof the first wing 340, with a trailing edge 344 that can act as a pushsurface. The first wing 340 may be coplanar with the cannula axis (notshown) of the cannula 326.

A tab 346 may be secured to the first wing 340. The tab 346 may beintegrally formed with the first wing 340, or may be formed separatelyfrom the first wing 340 and attached to the first wing 340 through anyof various methods known in the art. The tab 346 may extendsubstantially perpendicular to the plane of the first wing 340 or at amodest angle away from perpendicular to the plane of the first wing 340(e.g. any angle small enough to allow a proximally oriented surface ofthe tab 346 to serve as a push surface). Alternatively, the tab 346 mayextend from the first wing 340 along a direct nonparallel to the firstwing 340. Thus, the proximally oriented surface of the tab 346 may serveas a push surface, and may be oriented substantially perpendicular tothe cannula axis (not shown) of the cannula 326 or at a modest angleaway from perpendicular to the cannula axis as described.

The needle component 304 may have a needle hub 350, a grip 352, and aneedle 354. The needle hub 350 may have a generally cylindrical shapewith a proximal end 360 and a distal end 362. The needle hub 350 mayalso have a boss 364 that protrudes from the distal end 362 to interfacewith the needle port 336 of the catheter hub 320.

The grip 352 may have a generally planar shape, with an irregular,elongated shape when viewed from perpendicular to the plane of the grip352. The grip 352 may have a proximal portion 366 with a relativelynarrow shape, and a distal portion 368 with an enlarged shape. Theproximal portion 366 may extend outward from the needle hub 350, and maybe generally coplanar with the needle axis (not shown), and thus withthe axis of the needle hub 350. The distal portion 368 of the grip 352may have a leading edge 372, which may serve as a pull surface. The grip352 and/or the first wing 340 may have one or more grip features 370,such as raised nubs, bumps, or ridges of any desirable shape and number,or a high-friction surface applied to the first wing 340 or from which aportion of the first wing 340 may be formed, which may help provide asecure interface that facilitates gripping and/or moving the grip 352and/or the first wing 340 by hand.

The grip 352 and the first wing 340 may be rotatable, relative to eachother, about the cannula axis of the cannula 326 and the needle axis ofthe needle 354, which may be coincident in the insertion configurationshown in FIG. 3 . Thus, the clinician may rotate the grip 352 and/or thefirst wing 340 to the desired relative orientation prior to insertionand/or prior to motion to the fluid delivery configuration. In onemethod, the clinician may rotate the grip 352 relative to the first wing340 such that the tab 346 is sandwiched between the grip 352 and thefirst wing 340.

If desired, the IV catheter system 300 may have a flash receptacle (notshown), which may be similar to those of previous embodiments. The flashreceptacle may receive blood to provide visual confirmation of properplacement of the distal end of the cannula 326.

To move the IV catheter system 300 from the insertion configuration tothe fluid delivery configuration, the clinician may position a digit(for example, a finger) on the leading edge 372 of the grip 352, and adigit (for example, a finger or thumb) on the trailing edge 344 of thefirst wing 340 and/or the proximally oriented surface of the tab 346.The clinician may then pull the leading edge 372 proximally, and maypush and/or brace the trailing edge 344 of the first wing 340 and/or theproximally oriented surface of the tab 346 distally. This may cause thecatheter component 302 to remain in place while the needle component 304is withdrawn proximally from the catheter component 302.

FIG. 4 is a perspective view of an IV catheter system 400 according toanother alternative embodiment. The IV catheter system 400 may havecomponents that generally correspond to those of the IV catheter systemsof previous embodiments. FIG. 4 shows only a catheter component 402, aneedle component 404, and an extension tube 406. The IV catheter system400 may have a configuration similar to those of the IV catheter systemsof previous embodiments; however, some components may be modified,added, or omitted to provide alternative ergonomics and/orfunctionality.

The catheter component 402 may have a catheter hub 420, an extensiontubing junction 424, and a cannula 426. The catheter hub 420 may have agenerally tubular and/or hollow conical shape, with a proximal end 430and a distal end 432. The catheter hub 420 may have an exterior wallshaped to define a chamber (not shown) through which fluid flows toreach the fluid delivery location through the cannula 426. The catheterhub 420 may have a needle port 436 that connects to the needle component404, proximate the proximal end 430 of the catheter hub 420. Thecatheter hub 420 may also have a septum (not shown) positioned withinthe chamber. The septum may be a “low drag” septum as describedpreviously.

The catheter component 402 may not have a securement platform. Rather,if desired, the catheter hub 420 may be attached directly to the skin ofthe patient. Alternatively, any system or method known in the art forcatheter stabilization may be applied to the catheter component 402during fluid delivery to keep the catheter component 402 in place. Asanother alternative, the extension tubing junction 424 may be used tofacilitate comfortable placement of the catheter component 402 on thepatient's skin and/or attachment of the catheter component 402 to theskin.

A tab 446 may be secured to the catheter hub 420, and may extendoutwardly from the catheter hub 420. The tab 446 may be integrallyformed with the catheter hub 420, or may be formed separately from thecatheter hub 420 and attached to the catheter hub 420 through any ofvarious methods known in the art. The tab 446 may extend substantiallyperpendicular to the catheter hub 420 and/or a cannula axis (not shown)of the cannula 426. Alternatively, the tab 446 may extend at a modestangle away from perpendicular to the catheter hub and/or the cannulaaxis (e.g. any angle small enough to allow a proximally oriented surfaceof the tab 446 to serve as a push surface). Thus, the proximallyoriented surface of the tab 446 may serve as a push surface, and may beoriented substantially perpendicular to the cannula axis of the cannula426, or at a modest angle away from perpendicular to the cannula axis,as described. The tab 446 may optionally be positioned proximate theproximal end 430 of the catheter hub 420. Further, if desired, the tab446 may be positioned nearer to the proximal end 430 of the catheter hub420 than to the distal end 432 of the catheter hub 420. Positioning ofthe tab 446 near the proximal end 430 may make the proximally orientedsurface of the tab 446 more easily reachable for one or more digits ofthe hand, such as the thumb.

The needle component 404 may have a needle hub 450, a grip 452, and aneedle 454. The needle hub 450 may have a generally cylindrical shapewith a proximal end 460 and a distal end 462. The needle hub 450 mayalso have a boss (not shown) that protrudes from the distal end 462 tointerface with the needle port 436 of the catheter hub 420.

The grip 452 may have a generally planar shape, with an irregular,elongated shape when viewed from perpendicular to the plane of the grip452. The grip 452 may have a proximal portion 466 with a relativelynarrow shape, and a distal portion 468 with an enlarged shape. Theproximal portion 466 may extend outward from the needle hub 450, and maybe generally coplanar with the needle axis (not shown), and thus withthe axis of the needle hub 450. The distal portion 468 of the grip 452may have a leading edge 472, which may serve as a pull surface. The grip452 may have one or more grip features (not shown), which may helpprovide a secure interface that facilitates gripping and/or moving thegrip 452 by hand.

Further, another tab 474 may be secured to the distal portion 468 of thegrip 452. The tab 474 may be integrally formed with the grip 452, or maybe formed separately from the grip 452 and attached to the grip 452through any of various methods known in the art. The tab 474 may extendsubstantially perpendicular to the plane of the grip 452, or at a modestangle away from perpendicular to the plane of the grip 452 (e.g. anyangle small enough to allow a distally oriented surface of the tab 474to serve as a pull surface). Alternatively, the tab 474 may extend fromthe grip 452 along a direction nonparallel to the plate of the grip 452.Thus, the distally oriented surface of the tab 474 may serve as a pullsurface, and may be oriented substantially perpendicular to the needleaxis (not shown) of the needle 454, or at a modest angle away fromperpendicular to the needle axis, as described. The location of the tab474 may facilitate placement of a digit on the distally facing surfaceof the tab 474, thereby providing enhanced ergonomics, particularly forsingle-handed operation. The tab 474 and the tab 446 may thus cooperateto facilitate single-handed operation.

The grip 452 and the tab 446 may be rotatable, relative to each other,about the cannula axis of the cannula 426 and the needle axis of theneedle 454, which may be coincident in the insertion configuration shownin FIG. 4 . Thus, the clinician may rotate the grip 452 and/or the tab446 to the desired relative orientation prior to insertion and/or priorto motion to the fluid delivery configuration.

If desired, the IV catheter system 400 may have a flash receptacle (notshown), which may be similar to those of previous embodiments. The flashreceptacle may receive blood to provide visual confirmation of properplacement of the distal end of the cannula 426.

To move the IV catheter system 400 from the insertion configuration tothe fluid delivery configuration, the clinician may position a digit(for example, a finger) on the leading edge 472 of the grip 452 and/oron the tab 474, and a digit (for example, a finger or thumb) on theproximally oriented surface of the tab 446. The proximal/lateralposition of the leading edge 472, the tab 474, and/or the tab 446 mayfacilitate movement to the fluid delivery configuration. The clinicianmay then pull the leading edge 472 of the grip 452 and/or the tab 474proximally, and may push and/or brace the proximally oriented surface ofthe tab 446 distally. This may cause the catheter component 402 toremain in place while the needle component 404 is withdrawn proximallyfrom the catheter component 402.

FIGS. 5A and 5B are perspective views of an IV catheter system 500according to another alternative embodiment. The IV catheter system 500may have components that generally correspond to those of the IVcatheter systems of previous embodiments. FIGS. 5A and 5B show only acatheter component 502 and a needle component 504. Like the IV cathetersystem 300 of FIG. 3 , the IV catheter system 500 may be of an “open”type rather than an “integrated type,” and may thus not havepre-attached extension tubing. Rather, extension tubing may be coupledto the proximal end of the catheter component 502 to supply the fluid.The IV catheter system 500 may otherwise have a configuration similarthose of previous embodiments; however, some components may be modified,added, or omitted to provide alternative ergonomics and/orfunctionality.

The catheter component 502 may have a catheter hub 520, a securementplatform 522, and a cannula 526. The catheter hub 520 may have agenerally tubular and/or hollow conical shape, with a proximal end 530and a distal end 532. The catheter hub 520 may have a generallytranslucent exterior wall shaped to define a chamber 534 through whichfluid flows to reach the fluid delivery location through the cannula526. The catheter hub 520 may have a needle port 536 that connects tothe needle component 504, proximate the proximal end 530 of the catheterhub 520. The catheter hub 520 may also have a septum 538 positionedwithin the chamber 534. The septum 538 may be a “low drag” septum asdescribed previously. No extension tubing junction may be present, sincethe extension tubing is to be coupled to the proximal end 530 of thecatheter hub 520.

Further, the catheter hub 520 may have a kink resistance feature thathelps to avoid kinking of the cannula 526 during insertion and/orinfusion. The kink resistance feature may take the form of a proximalextension 528 on the distal end 532 of the catheter hub 520. Theproximal extension 528 may receive the cannula 526, and may provide someresistance to bending of the cannula 526 at the juncture of the cannula526 to the distal end 532 to relieve the bending strain at thatlocation, thereby helping avoid kinking or other undesired bending ofthe cannula 526. If desired, the proximal extension 528 may be formed ofa more flexible material than that of the remainder of the catheter hub520, so as to allow some flexure to help prevent kinking.

The securement platform 522 may be attached to the skin of the patientduring fluid delivery to keep the cannula 526 in place at the fluiddelivery location. The securement platform 522 may have a first wing540, which may be generally planar in shape. The first wing 540 may havea generally triangular and/or elliptical shape when viewed fromperpendicular to the plane of the first wing 540, with a trailing edge544 that can act as a push surface. The first wing 540 may be coplanarwith the cannula axis (not shown) of the cannula 526.

The needle component 504 may have a needle hub 550, a first grip 552, asecond grip 553, and a needle 554. The needle hub 550 may have agenerally cylindrical shape with a proximal end 560 and a distal end562. The needle hub 550 may also have a boss 564 that protrudes from thedistal end 562 to interface with the needle port 536 of the catheter hub520.

The first grip 552 may have a generally planar shape, with an irregular,elongated shape when viewed from perpendicular to the plane of the firstgrip 552. The first grip 552 may have a proximal portion 566 with arelatively narrow shape, and a distal portion 568 with an enlargedshape. The proximal portion 566 may extend outward from the needle hub550, and may be generally coplanar with the needle axis (not shown), andthus with the axis of the needle hub 550. The distal portion 568 of thefirst grip 552 may have a leading edge (not shown), which may serve as apull surface.

The second grip 553 may have a generally planar shape, with generallytruncated elliptical shape when viewed from perpendicular to the planeof the second grip 553. The second grip 553 may extend outward from theneedle hub 550, and may be generally coplanar with the needle axis (notshown), and thus with the axis of the needle hub 550. The second grip553 may also be generally coplanar with the first grip 552. The secondgrip 553 may have a leading edge 572, which may serve as a pull surface.The second grip 553 may be positioned proximally of the first grip 552,though in the insertion configuration, the leading edge 572 of thesecond grip 553 may still be positioned proximally of the proximal end530 of the catheter hub 520. Thus, the second grip 553 may provideadditional options for a clinician to grasp the needle component 504,particularly during insertion of the IV catheter system 500 and/ormotion of the IV catheter system 500 from the insertion configuration tothe fluid delivery configuration. In particular, the leading edge 572 ofthe second grip 553 may be positioned such that a digit of theclinician's hand, such as the thumb, can easily contact and exertproximal pressure on the leading edge 572. Additionally oralternatively, the second grip 553 may facilitate use of a second handto assist in moving the IV catheter system 500 from the insertionconfiguration to the fluid delivery configuration.

The first grip 552, the second grip 553, and/or the first wing 540 mayhave one or more grip features 570, such as raised nubs, bumps, orridges of any desirable shape and number, or a high-friction surfaceapplied to the first grip 552, the second grip 553, and/or the firstwing 540 or from which a portion of the first grip 552, the second grip553, and/or the first wing 540 may be formed, which may help provide asecure interface that facilitates gripping and/or moving the first grip552 and/or any other portion of the IV catheter system 500 by hand. Thefirst grip 552 and the second grip 553 may be rigidly secured togethervia the needle hub 550, but may both be rotatable relative to the firstwing 540 about the cannula axis of the cannula 526 and the needle axisof the needle 554, which may be coincident in the insertionconfiguration shown in FIG. 5A. Thus, the clinician may rotate the firstgrip 552, the second grip 553, and/or the first wing 540 to the desiredrelative orientation prior to insertion and/or prior to motion to thefluid delivery configuration.

If desired, the first grip 552 and the first wing 540 may be relativelyoriented such that they are parallel or generally parallel to eachother, and are positioned in close proximity to each other. Thus, thefirst grip 552 and the first wing 540 may be positioned in abuttingrelation to each other in the insertion configuration and during theinitial stages of motion from the insertion configuration to the fluiddelivery configuration. During motion from the insertion configurationto the fluid delivery configuration, the first grip 552 may slide alongthe first wing 540. In order to maintain the desired relativepositioning between the first grip 552 and the first wing 540, the firstgrip 552 and/or the first wing 540 may have one or more alignmentfeatures (not shown) that maintain relative positioning and/ororientation between the first wing 540 and the first grip 552. Variouscombinations of ridges, troughs, and/or other features may be used asalignment features.

Such alignment features may help to mitigate the bending moments thatmay be exerted on the catheter component 502 and/or the needle component504 by virtue of imbalanced forces applied to the catheter component 502and/or the needle component 504, thereby helping the catheter component502 and the needle component 504 remain properly aligned until the IVcatheter system 500 is in the fluid delivery configuration. Thus,binding and/or other undesired interactions between the cathetercomponent 502 and the needle component 504 may be avoided during motionfrom the insertion configuration to the fluid delivery configuration.

Further, the first wing 540 and/or the first grip 552 may have one ormore locking features (not shown) that help to keep the IV cathetersystem 500 in the insertion configuration until the clinician applies athreshold disengagement force sufficient to detach the needle component504 from the catheter component 502. Various interlocking features suchas clips, tabs, detents, recesses, and/or the like may be used aslocking features to provide the desired threshold disengagement force.

If desired, the IV catheter system 500 may have a flash receptacle (notshown), which may be similar to those of previous embodiments. The flashreceptacle may receive blood to provide visual confirmation of properplacement of the distal end of the cannula 526.

To move the IV catheter system 500 from the insertion configuration tothe fluid delivery configuration, the clinician may position a digit(for example, a finger) on the leading edge of the first grip 552 and/oron the leading edge 572 of the second grip 553, and a digit (forexample, a finger or thumb) on the trailing edge 544 of the first wing540. The clinician may then pull the leading edge of the first grip 552and/or on the leading edge 572 of the second grip 553 proximally, andmay push and/or brace the trailing edge 544 of the first wing 540distally. This may cause the catheter component 502 to remain in placewhile the needle component 504 is withdrawn proximally from the cathetercomponent 502.

FIG. 6 is a flowchart diagram depicting one method of preparing an IVcatheter system to deliver fluid to a patient, according to oneembodiment. The method of FIG. 6 may be carried out with any of the IVcatheter systems disclosed in FIGS. 1 through 5B or with any of the IVcatheter systems disclosed with respect FIGS. 7-9B as will be discussedbelow, or with other IV catheter system embodiments that are notspecifically shown or described herein. By way of example, the methodwill be described in connection with the IV catheter system 100 of FIG.1 . Further, the method of FIG. 6 is merely exemplary; other methods maybe used in conjunction with any of the IV catheter system embodimentsincluded within the scope of the present disclosure.

The method may start 610 with a step 620 in which the IV catheter system100 is prepared. This preparation may include connecting variouscomponents (such as the catheter component 102, the needle component104, the extension tube 106, the clamp 108, the Y adapter 110, and/orthe flash receptacle 112 of FIG. 1 , by way of example) together.Further, this may include preparing any adhesives needed or desired tosecure the catheter component 102 to the patient, preparing componentsof the fluid source to be connected to the IV catheter system 100,and/or the like.

In a step 630, the IV catheter system 100 may be grasped with a singlehand. This may involve placing digits of the hand to contact the pullsurface(s) of the needle component 104 and the push surface(s) of thecatheter component 102, as described above. Notably, the surfaces thatserve as pull surfaces and push surfaces may vary, depending on thespecific embodiment utilized. Further, catheter insertion may involveprimarily pushing; accordingly, the clinician may elect not to makecontact with the pull surfaces at this stage, but to contact them whenthe IV catheter system 100 is to be moved to the fluid deliveryconfiguration.

In a step 640, the IV catheter system 100 may be manipulated to insertthe cannula 126 into the patient. This may optionally be done with asingle hand. Insertion may continue until the tip of the cannula 126 hasreached the fluid delivery location. Insertion may be carried out bypushing on the push surface(s) and/or other surfaces of the cathetercomponent 102 and/or the needle component 104, and the clinician mayfurther utilize contact with the pull surface(s) of the needle component104 and/or other surfaces of the catheter component 102 and/or theneedle component 104 to steady and/or guide placement of the cannula126. The clinician may confirm proper insertion of the cannula 126 byobserving blood flow into the flash chamber 114 of the flash receptacle112.

In a step 650, the IV catheter system 100 may be moved from theinsertion configuration to the fluid delivery configuration. If theclinician has not yet contacted the pull surface(s) of the needlecomponent 104, he or she may do this now with one or more digits of ahand. Optionally, the same hand used to insert the IV catheter system100 may be used, exclusively (i.e., without assistance from the otherhand) to move the IV catheter system 100 to the fluid deliveryconfiguration. The clinician may pull the pull surface(s) proximally,while pushing or bracing on the push surface(s) to keep the cathetercomponent 102 in place. Thus, the catheter component 102 may be kept inplace with the tip of the cannula 126 at the fluid delivery locationwhile the needle component 104 is withdrawn proximally from the cathetercomponent 102 to unblock the fluid delivery path to the fluid deliverylocation.

This may optionally be accomplished with a single hand. Thus, the otherhand may be used to perform other tasks during insertion and/or motionof the IV catheter system 100 to the fluid delivery configuration. Forexample, the clinician may use the other hand to hold the patient's arm(or other body part in which the fluid delivery location is located),prepare other components for interconnection with the IV catheter system100, prepare any necessary blood testing materials, and/or the like.

The method may then end 690. With the IV catheter system 100 in thefluid delivery configuration, the fluid source may then be connected tothe catheter component 102 to deliver the fluid to the patient, or ifthe fluid source was previously connected to the catheter component 102,the clamp 108 may be actuated so as to unblock flow from the fluidsource to the catheter component 102.

FIG. 7A illustrates another embodiment of an IV catheter system 700 thatincludes a rotation stop feature 762 a formed on needle hub 750.Although the IV catheter system 700 is substantially similar instructure in many regards to the IV catheter system 200, a similarrotation stop feature could also be formed on many of the otherabove-described embodiments of IV catheter systems. As can be seen inFIG. 7A, many of the features of the IV catheter system 700 are the sameas or similar to features of the other IV catheter systems, andtherefore these features will not be redundantly described.

The catheter component of the IV catheter system 700 includes a first(or left) wing 740 that is placed similarly to the first wing 240 in theIV catheter system 200. Also, the needle component of the IV cathetersystem 700 includes a grip 752 that is placed similarly to the grip 252of the IV catheter system 200. Accordingly, as described above, theneedle component can be rotated with respect to the catheter componentto position the grip 752 and the first wing 740 in a desiredorientation. However, with reference to the design of the IV cathetersystem 200, one potential drawback of this ability to rotate the needlecomponent 204 is that it allows the grip 252 to freely sag. In otherwords, while the IV catheter system 200 is being manipulated, the weightof the grip 252 may cause the needle component 204 to rotate to thepoint that the grip 252 hangs directly below the catheter component 202thereby making it more inconvenient to position the grip 252 in theappropriate location to manipulate the catheter system 200 to theinsertion configuration and/or to the fluid delivery configuration.

To address this issue, IV catheter systems such as the IV cathetersystem 700 can include the rotation stop feature 762 a which functionsto limit how far the needle component can rotate in the direction 795while the needle component is coupled to the catheter component. Asshown, the rotation stop feature 762 a comprises a distally protrudingportion from the distal end of needle hub 750 which forms an upwardlyfacing ledge that can catch underneath a portion 740 a of the first wing740. In some embodiments, a rotation stop feature of the presentinvention may comprise a plurality of ledges or other surfaces which areutilized to limit rotation of the needle component.

The rotation stop feature 762 a can be positioned so that, when itcontacts the portion 740 a, the grip 752 will be substantially inline orsubstantially coplanar with the first wing 740. In other words, therotation stop feature 762 a can retain the grip 752 in a generally flatorientation. However, because the rotation stop feature 762 a forms anupwardly facing ledge, it will not prevent the grip 752 from beingrotated in a direction opposite the direction 795. Therefore, the grip752 may still be rotated overtop of the first wing 740 to accommodatedifferent grip techniques.

Alternatively, a rotation stop feature could be formed on the needlecomponent that contacts a different portion of the catheter component.For example, the catheter component can include a protrusion thatinterfaces with a notch or protrusion formed in the needle component tolimit rotation of the needle component in the same manner describedabove. Also, the rotation stop feature 762 a could be configured tocontact a portion of the catheter component other than first wing 740.

It is noted that FIG. 7A depicts an embodiment of an IV catheter systemthat is designed primarily for right-handed insertion. However, theorientation of the components could be reversed in a design that isprimarily intended for left-handed insertion. In other words, the firstwing 740 and the extension tube could extend from the right side of thecatheter component while the grip 752 could extend from the left side ofthe needle component. In such a design, the rotation stop feature 762 acould also be oppositely oriented to prevent over-rotation in thedirection opposite the direction 795. Also, a similar rotation stopfeature could be incorporated into the other embodiments of IV cathetersystems described herein.

FIG. 7B illustrates an embodiment of an IV catheter system 700 thatincludes a flash receptacle having a side vent 701. Although the IVcatheter system 700 is configured in many regards similar to the IVcatheter system 700 of FIG. 7A, a similar side vent could beincorporated into any of the above-described embodiments having a needlecomponent that includes a flash chamber.

Although not visible in FIG. 7B, the proximal end of the needlecomponent can include an opening through which air can be vented asflash flows into the flash chamber formed within the flash receptacle ofthe needle component. In some gripping techniques, the clinician mayplace a digit (e.g., the thumb or a finger) overtop this proximalopening thereby minimizing or preventing the venting of air from theflash chamber. To address this, the flash receptacle of the IV cathetersystem 700 of FIG. 7B can include one or more side vents 701 which mayfunction to vent air from the flash chamber even if the proximal openingis covered. Each of the side vents 701 can be positioned proximal to anymembrane or other blood-flow-inhibiting structure contained within theflash chamber so that blood is prevented from exiting through the sidevent 701. In some embodiments, the flash receptacle may not include aproximal opening and therefore may rely only on the one or more sidevents 801 for venting.

FIG. 8 illustrates an embodiment of an IV catheter system 800 thatincludes an alternative rotation stop feature 862 b formed as aninternal notch on the needle hub. The IV catheter system 800 alsoincludes a corresponding rotation stop feature on the catheter hub, inthis case tab 863. As illustrated in FIG. 8 , the rotation stop feature862 b and the notch 863 may be formed to essentially entirely preventany rotation of the needle hub relative to the catheter hub. In otherwords, the notch of rotation stop feature 862 b may be limited in sizeto prevent more than minimal rotation. In other embodiments, the notchof rotation stop feature 862 b may be enlarged circumferentially topermit any desired extent of rotation of the needle hub relative to thecatheter hub. The IV catheter system 800 may have components thatgenerally correspond to those of the IV catheter systems of previousembodiments, and such features will not be redundantly described. Whilethe IV catheter system 800 of FIG. 8 may be of the integrated type, theadditional features discussed with respect to the catheter system 800may also be applied to alternative embodiments including open and safetyintegrated IV catheter systems.

In some embodiments one or more additional features may be provided toserve as push and/or pull surfaces to facilitate one-handed motion ofthe IV catheter system between the insertion configuration and the fluiddelivery configuration. For example, the flash receptacle of the variousembodiments described above may be replaced with a cylindricallow-volume/high-visualization flash chamber that is adapted to beinserted into the needle component. Additionally, one or more grips maybe applied to sides of the flash receptacle and/or other portions of theneedle component to facilitate a central grip insertion technique wherethe side grips of the flash receptacle/needle component are used ininsertion and/or moving to the fluid delivery configuration.Additionally, a further example of a push surface may be provided in theform of a raised circumferential ring of soft and/or flexible materialapplied to the catheter hub of the catheter component. In someembodiments, the soft and/or flexible material comprises a durometerhardness of from approximately 30 Shore A to approximately 90 Shore D.In some embodiments, the soft and/or flexible material comprises adurometer hardness of from approximately 50 Shore A to approximately 90Shore D. Any further modification provided to any component to providefurther surfaces on which to push or pull to accomplish techniquessimilar to those discussed herein are embraced as falling within thespirit of the invention.

FIGS. 9A and 9B are perspective views of an IV catheter system 900according to another alternative embodiment. The IV catheter system 900may have components that generally correspond to those of the IVcatheter systems of previous embodiments, and such features will not beredundantly described. While the IV catheter system 900 of FIGS. 9A and9B may be of the integrated type, the additional features discussed withrespect to the catheter system 900 may also be applied to alternativeembodiments including open and safety integrated IV catheter systems.

As discussed with the IV catheter systems 700 of FIGS. 7A and 7B, acatheter component 902 of the IV catheter system 900 includes a wing 940that is adapted to contact a corresponding rotation stop feature 962 aof a needle component 904. The rotation stop feature 962 a functionswith the wing 940 to limit how far the needle component can rotaterelative to the catheter component while the needle component is coupledto the catheter component. The function of the rotation stop feature 962a is essentially similar to the function of the rotation stop feature762 a.

The catheter component 902 includes an additional feature that may serveas a push feature that facilitates movement of the IV catheter system900 from the insertion configuration generally shown in FIG. 9A to thefluid delivery configuration, the movement between configurations beingillustrated in FIG. 9B. The additional feature is a circumferential ring948 disposed around a catheter hub 920 of the catheter component 902.The circumferential ring 948 may be manufactured of a material that isrelatively soft to the touch and/or that provides a relatively highcoefficient of friction to facilitate secure reception of a tip of adigit thereon to facilitate movement of the IV catheter system 900 fromthe insertion configuration to the fluid delivery configuration.Additionally or alternatively, the circumferential ring 948 may beformed of a relatively rigid material. Additionally or alternatively,the circumferential ring 948 may be formed with a textured surface, suchas a surface having ridges, bumps, or nubs.

Additional features are also provided to the needle component 904 thatmay serve as additional pull features to facilitate movement of the IVcatheter system 900 from the insertion configuration to the fluiddelivery configuration. Specifically, a pair of central grips 976 may beaffixed to opposing sides of a needle hub 950 of the needle component904. The central grips 976 may be formed of a material that isrelatively soft to the touch and/or that provides a relatively highcoefficient of friction to facilitate securing the needle component 904by gripping the central grips 976 in a pinching motion, whereby apulling force can be applied to the needle component 904 while a pushingor bracing force is applied to the catheter component 902, such as usingthe circumferential ring 948. Additionally or alternatively, the centralgrips 976 may be formed of a relatively rigid material. Additionally oralternatively, the central grips 976 may be formed with a texturedsurface, such as a surface having ridges, bumps, or nubs, as isillustrated in FIGS. 9A and 9B.

The additional push and pull features illustrated in FIGS. 9A and 9Bprovide alternative mechanisms by which the IV catheter system 900 maybe inserted in the insertion configuration and/or moved from theinsertion configuration to the fluid delivery configuration with asingle hand. In some alternative embodiments of an IV catheter system,some of the various push and pull features discussed herein may beomitted in favor of the additional push and pull features discussed withrespect to FIGS. 9A and 9B. Thus, the specific combination of push andpull features illustrated in FIGS. 9A and 9B is not intended to belimiting of the use of circumferential rings such as circumferentialring 948 and/or central grips such as central grips 976, as may beillustrated by the inclusion of central grips 876 on the IV cathetersystem 800 of FIG. 8 without the inclusion of a correspondingcircumferential ring, but instead with the inclusion of tabs 846analogous to the tab 446 of the IV catheter system 400 of FIG. 4 .

FIGS. 9A and 9B illustrate an additional feature that may beincorporated into certain embodiments of IV catheter systems, namely alow-volume high-visualization flash chamber 914. The low-volumehigh-visualization flash chamber 914 may be fixedly or removablyreceived within a flash receptacle 112 of the needle hub 950 of theneedle component 904. When the low-volume high-visualization flashchamber 914 is removably received in the flash receptacle 112, it may beinserted through an opening in a proximal end of the needle hub 950, asillustrated by direction 997.

Various embodiments of the present invention may further comprise aneedle safety mechanism configured to secure the sharpened, distal tipof the introducer needle following removal and separation of the variousembodiments of the needle component from the various embodiments of thecatheter component to prevent accidental needle sticks. A safetymechanism may include any compatible device known in the art. In someinstances, the safety mechanism is configured to interact with a needlefeature, such as a ferrule, notch, crimp or bump on the needle. Thecrimp or bump formed in the needle causes a slight out of roundconfiguration that can be used to activate a safety mechanism. In someinstance, the safety mechanism comprises an arm or lever that isactuated to capture the needle tip within the mechanism and prevent thetip from emerging prior to safe disposal.

The safety mechanism may be coupled with the particular IV cathetersystem in any number of ways. In some embodiments, the safety mechanismmay include an internal interlock in which the safety mechanism iscoupled with an internal surface of a catheter component. Coupling mayinclude threading, fitting, snapping, connecting, attaching, fastening,clipping, hooking, or any other suitable means of coupling. Non-limitingexamples of safety mechanisms that include an internal interlock areprovided in: U.S. Pat. No. 8,496,623, titled BI-DIRECTIONAL CANNULAFEATURE CAPTURE MECHANISM, filed Mar. 2, 2009; U.S. Pat. No. 9,399,120,titled BI-DIRECTIONAL CANNULA FEATURE CAPTURE MECHANISM, filed Jul. 11,2013; U.S. Patent Application No. 62/314,262, titled CANNULA CAPTUREMECHANISM, filed Mar. 28, 2016, each of which is herein incorporated byreference in its entirety. In some embodiments, the safety mechanism mayinclude a clip disposed within the catheter component, a non-limitingexample of which is provided in U.S. Pat. No. 6,117,108, titled SPRINGCLIP SAFETY IV CATHETER, filed Jun. 12, 1998, which is hereinincorporated by reference in its entirety.

In some embodiments, the safety mechanism may include an externalinterlock in which the safety mechanism is coupled with an externalsurface of the catheter component. In some embodiments, the safetymechanism may be coupled with an external surface of the cathetercomponent and an internal and/or external surface of a needle hub.Coupling may include threading, fitting, snapping, connecting,attaching, fastening, clipping, hooking, or any other suitable means ofcoupling. Non-limiting examples of safety mechanisms that include anexternal interlock are provided in U.S. patent application Ser. No.14/295,953, titled PORTED IV CATHETER HAVING EXTERNAL NEEDLE SHIELD ANDINTERNAL BLOOD CONTROL SEPTUM, filed Jun. 4, 2014, which is hereinincorporated by reference in its entirety. In some embodiments, thesafety mechanism may include a V-clip or a similar clip. A non-limitingexample of a V-clip is provided in U.S. patent application Ser. No.14/295,953, titled PORTED IV CATHETER HAVING EXTERNAL NEEDLE SHIELD ANDINTERNAL BLOOD CONTROL SEPTUM, filed Jun. 4, 2014, which is hereinincorporated by reference in its entirety. The V-clip may selectivelyretain a portion of the catheter component.

In some embodiments, a defeatable mechanical connection is providedbetween the safety mechanism and at least one other component of the IVcatheter system. In some instances, the mechanical connection isdefeated upon securement of the distal tip of the needle within thesafety mechanism. In some embodiments, a surface of the safety mechanismis selectively coupled to one or more of the following: the cathetercomponent, a blood control valve, an extension tube, and one or morepaddle grips.

In some embodiments, the safety mechanism may include a safety barrel,which may be spring-loaded. For example, the safety barrel may be springloaded as in the BD™ Insyte® Autoguard™ BC shielded protective IVcatheter. In some embodiments, the safety mechanism may be passivelyand/or actively activated. In some embodiments, the safety mechanism maybe configured to interact with a needle feature, such as a ferrule,notch, crimp or bump on the needle. In some embodiments, the safetymechanism may include an arm or lever that may be actuated to capturethe distal tip within the safety mechanism and prevent the tip fromemerging prior to safe disposal. In some embodiments, the safetymechanism may be attached to a body of the needle and may be capable ofsliding along the length thereof.

In some embodiments, in an assembled position prior to catheterization,the safety mechanism may be disposed between the catheter component andthe needle hub. In some embodiments, the catheter component and theneedle hub may be spaced apart by at least a portion of the safetymechanism in the assembled position prior to catheterization. In someembodiments, in the assembled position prior to catheterization, aproximal end of the catheter component may be disposed between a distalend of the safety mechanism and a distal end of a grip of the needlehub, such as, for example, a paddle grip. In some embodiments, in theassembled position prior to catheterization, the proximal end of thecatheter component may be disposed between the distal end of the safetymechanism and a proximal end of the grip of the needle hub. In someembodiments, a portion of the safety mechanism may overlap with aportion of the grip of the needle hub. In some embodiments, at least aportion of at least one of the catheter component and the grip overlapsat least some portion of the safety mechanism. In some embodiments, noportion of the catheter component or the grip overlaps any portion ofthe safety mechanism.

The present invention may be embodied in other specific forms withoutdeparting from its structures, methods, or other essentialcharacteristics as broadly described herein and claimed hereinafter. Thedescribed embodiments are to be considered in all respects only asillustrative, and not restrictive. The scope of the invention is,therefore, indicated by the appended claims, rather than by theforegoing description. All changes that come within the meaning andrange of equivalency of the claims are to be embraced within theirscope.

We claim:
 1. An intravenous (IV) catheter system comprising an insertionconfiguration and a fluid delivery configuration, the IV catheter systemcomprising: a catheter component comprising: a catheter hub comprising acatheter hub distal end and a catheter hub proximal end, wherein thecatheter hub defines a chamber extending between the catheter hub distalend and the catheter hub proximal end, and a needle port at the catheterhub proximal end that provides access to the chamber; a cannulaextending distally from the catheter hub distal end; and a push featureconnected to the catheter hub and defining a push surface of thecatheter component; a needle component comprising: a needle hubcomprising a needle hub distal end; a needle extending distally from theneedle hub distal end; and a pull feature connected to the needle huband defining a pull surface of the needle component; wherein, in theinsertion configuration, the needle is positioned within the cannula,the needle hub distal end is seated in the needle port, and the pullsurface is positioned distal the catheter hub proximal end.
 2. The IVcatheter system of claim 1, wherein the pull surface is positioneddistal the push surface when the IV catheter system is in the insertionconfiguration.
 3. The IV catheter system of claim 1, wherein the pushfeature comprises a feature selected from the group consisting of: atrailing edge of a wing secured to the catheter hub, the wing beinggenerally parallel to an axis of the cannula; a grip feature applied toor formed on a major surface of a wing secured to the catheter hub, thewing being generally parallel to an axis of the cannula; a series ofnubs applied to or formed on a major surface of a wing secured to thecatheter hub, the wing being generally parallel to an axis of thecannula; a tab secured to a wing, the wing being secured to the catheterhub and being generally parallel to an axis of the cannula, and the tabextending from the wing in a direction nonparallel to the wing; a tabsecured to a wing, the wing being secured to the catheter hub and beinggenerally parallel to an axis of the cannula, and the tab extendingsubstantially perpendicularly from the wing; a tab secured to andextending outwardly from the catheter hub; a circumferential ringdisposed around the catheter hub; and a proximal surface of an extensiontubing junction extending from the catheter hub.
 4. The IV cathetersystem of claim 3, wherein the push feature is integrated into asecurement platform comprising a wing extending from the catheter hubgenerally parallel to a cannula axis along which the cannula extendssuch that, in the fluid delivery configuration, the wing rests on skinof a patient receiving fluid through the IV catheter system.
 5. The IVcatheter system of claim 4, wherein the wing is integrated with anextension tubing junction extending outwardly from the catheter hub at alocation intermediate the catheter hub distal end and the catheter hubproximal end.
 6. The IV catheter system of claim 4, wherein the wing isnot coplanar with a cannula axis containing the cannula.
 7. The IVcatheter system of claim 1, wherein the catheter component furthercomprises a septum within the chamber through which the needle passes inthe insertion configuration and wherein the septum is configured toprovide a sufficiently low resistance to withdrawal of the needlethrough the septum to enable a single hand of a clinician to move the IVcatheter system from the insertion configuration to the fluid deliveryconfiguration without assistance of another hand of the clinician. 8.The IV catheter system of claim 1, wherein the pull feature comprises afeature selected from the group consisting of: a leading edge of a gripsecured to the needle hub and extending outwardly and generally distallyfrom the needle hub; a grip feature applied to or formed on a majorsurface of a grip secured to the needle hub and extending outwardly andgenerally distally from the needle hub; a series of nubs applied to orformed on a major surface of a grip secured to the needle hub andextending outwardly and generally distally from the needle hub; a tabsecured to a grip, the grip being secured to the needle hub andextending outwardly and generally distally from the needle hub generallyparallel to an axis of the needle, and the tab extending from the gripin a direction nonparallel to the grip; and a tab secured to a grip, thegrip being secured to the needle hub and extending outwardly andgenerally distally from the needle hub generally parallel to an axis ofthe needle, and the tab extending substantially perpendicularly from thegrip.
 9. The IV catheter system of claim 1, wherein: the cathetercomponent comprises a wing extending outwardly from the catheter hubgenerally parallel to a cannula axis; the needle component comprises agrip extending outwardly and distally from the needle hub generallyparallel to a needle axis; in the insertion configuration, the wing andthe grip are generally parallel to each other and are positioned inabutting relation to each other; and during motion of the IV cathetersystem from the insertion configuration to the fluid deliveryconfiguration, the grip slides along the wing.
 10. The IV cathetersystem of claim 1, wherein the needle component comprises a rotationstop feature formed proximate the needle hub distal end, the rotationstop feature being configured to engage a corresponding feature on thecatheter component to limit rotation of the needle component relative tothe catheter component.
 11. The IV catheter system of claim 10, wherein:the catheter component comprises a wing extending outwardly from thecatheter hub generally parallel to a cannula axis; the needle componentcomprises a grip extending outwardly and distally from the needle hubgenerally parallel to a needle axis; the rotation stop feature extendsdistally from the needle hub distal end; in the insertion configuration,the needle component is rotated relative to the catheter component suchthat the rotation stop feature contacts the wing of the cathetercomponent and the grip is substantially co-planar with the wing.
 12. TheIV catheter system of claim 11, further comprising: a circumferentialring extending around the catheter hub; a low-drag septum disposedwithin the catheter hub; opposed side grips disposed on opposing sidesof the needle hub; and a low-volume, high-visualization flash chamberremovably attached to a flash receptacle attached to a proximal end ofthe needle hub.
 13. The IV catheter system of claim 1, wherein theneedle component comprises a needle hub proximal end having a flashreceptacle containing a flash chamber.
 14. The IV catheter system ofclaim 13, wherein the flash receptacle includes one or more side ventsfor venting air from the flash chamber.
 15. An intravenous (IV) cathetersystem comprising an insertion configuration and a fluid deliveryconfiguration, the IV catheter system comprising: a catheter componentcomprising: a catheter hub comprising a catheter hub distal end and acatheter hub proximal end, wherein the catheter hub defines a chamberextending between the catheter hub distal end and the catheter hubproximal end, and a needle port at the catheter hub proximal end thatprovides access to the chamber; a cannula extending distally from thecatheter hub distal end; and a wing connected to the catheter hub andextending outwardly from the catheter hub, the wing comprising a pushsurface of the catheter component; a needle component comprising: aneedle hub comprising a needle hub distal end; a needle extendingdistally from the needle hub distal end; and a grip connected to theneedle hub and extending outwardly and distally from the needle hub, thegrip comprising a pull surface of the needle component; wherein, in theinsertion configuration, the needle is positioned within the cannula,the needle hub distal end is seated in the needle port, and the pullsurface is positioned distal the catheter hub proximal end.
 16. The IVcatheter system of claim 15, wherein the pull surface is positioneddistal the push surface when the IV catheter system is in the insertionconfiguration.
 17. The IV catheter system of claim 15, wherein the pushsurface comprises a surface selected from the group consisting of: atrailing edge of the wing; a grip feature applied to or formed on amajor surface of the wing; a series of nubs applied to or formed on amajor surface of the wing; a tab secured to the wing, the tab extendingfrom the wing in a direction nonparallel to the wing; a tab secured tothe wing, the tab extending substantially perpendicularly from the wing;a proximal surface of an extension tubing junction extending from thecatheter hub and integrated with the wing.
 18. The IV catheter system ofclaim 15, wherein the pull surface comprises a surface selected from thegroup consisting of: a leading edge of the grip; a grip feature appliedto or formed on a major surface of the grip; a series of nubs applied toor formed on a major surface of the grip; a tab secured to the grip, thetab extending from the grip in a direction nonparallel to the grip; anda tab secured to the grip, the tab extending substantiallyperpendicularly from the grip.
 19. An intravenous (IV) catheter systemcomprising: a catheter component comprising: a catheter hub having aproximal end; a cannula that extends distally from the catheter hub; anda wing that extends outwardly from a side of the catheter hub; and aneedle component comprising: a needle hub having a distal end thatcouples to the proximal end of the catheter hub; a needle that extendsdistally from the distal end of the needle hub; a grip that extendsoutwardly and distally from a side of the needle hub; and a rotationstop feature formed at the distal end of the needle hub, the rotationstop feature being adapted to contact the wing of the catheter componentto limit rotation of the needle component with respect to the cathetercomponent when the needle is fully inserted in the cannula.
 20. The IVcatheter system of claim 19, wherein: the rotation stop feature extendsdistally from the distal end of the needle hub; and when the rotationstop feature contacts the wing, a plane of the grip is substantiallyparallel to a plane of the wing.